Infrared coagulation or photocoagulation is well known to medical science. It is a technique in which abnormal tissue is exposed to a burst of infrared energy. This heats the tissue locally, causing blood in veins in the tissue to coagulate (harden) and the abnormal tissue to shrink. Photocoagulation is a somewhat less aggressive method of tissue transformation than other known methods such as electrocautery, cryotherapy, laser ablation or argon plasma coagulation.
Infrared coagulation for outpatient treatment of internal first and second degree hemorrhoids and some third degree ones is known. In the known method, high intensity infrared light is transmitted through a rigid quartz probe which is inserted directly into the rectum and infrared energy applied for 1.5 to 2 seconds three to eight times to a localized area of hemorrhoids to coagulate vessels and tether the mucosa to subcutaneous tissues. Generally only one section of the hemorrhoids is treated per visit. Patients generally have three areas that need treatment and so have to return several times at intervals until all have been controlled. Infrared coagulation is quick (10 to 15 minutes a visit), effective, and painless, and patients can return immediately or the next day. Eighty per cent of patients treated by this conventional method are reported to be free of symptoms at three months.
A drawback of existing infrared coagulation treatment is that it is a “blind” procedure, in the sense that the physician has difficulty seeing the area being treated. For this reason, infrared coagulation can be inaccurate, increasing the need for multiple repeat treatments. There is a need for an improved apparatus and method for treatment of hemorrhoids which can be used in conjunction with a flexible colonoscope or sigmoidoscope, providing the physician with direct visualization of the treatment site, and from numerous directions and angles, facilitating pinpoint accuracy of treatment and immediate visual confirmation of the location and extent of treatment. The present invention addresses this need.
The apparatus of the invention for delivering infrared energy to a material comprises a source of infrared radiation which is not a laser, an elongated flexible fiber optic member for transmitting radiation from the source from a proximal end of the member to a distal end of the member and to a material proximate the distal end, and a connector on the proximal end of the elongated member for quickly connecting the member to and disconnecting the member from the apparatus where the member is aligned for receiving infrared radiation from the source. In the preferred embodiment, the apparatus is an endoscopic infrared coagulation apparatus for use in an accessory channel of an endoscope to coagulate targeted tissue within a human or animal subject.
The apparatus is a contact-type apparatus in that the elongated member includes at the distal end of the member a contact portion for contacting the material to be treated, the contact portion defining a size, direction and shape of a radiation delivery area from the member to a material to be treated proximate the contact portion. The use of a multiple wavelength, non-coherent source of infrared radiation, e.g. not a laser, in the contact type apparatus rather than a converging laser beam focused from above the material which must pass through intervening body fluids, for example, in the case of treating internal human tissue, that can possibly disrupt the beam and treatment and cause errors in treating the correct site, allows the safe and efficient transmission and delivery of infrared radiation to a highly specific location. The delivery is through a small-diameter, highly flexible component which can be used in highly articulated positions, such as in a 180 degree bend or in a “retroflexed” position in a flexible endoscope. The apparatus requires no gas for its use and requires intimate contact between the contact portion of the distal end of the elongated flexible fiber optic member and the target tissue in order for significant transfer of infrared energy to occur, making it less likely for inadvertent energy transfer and tissue damage than with a laser, which can irradiate significant energy without being in contact with the tissue.
In the example embodiments, the source of infrared radiation is an infrared lamp which radiates electromagnetic energy primarily in the infrared region, but which includes both visible and infrared radiation for transmission through the elongated member. The elongated member in the example embodiments includes an inner flexible fiber optic body and outer protective sheath, the inner flexible fiber optic body being a multicomponent transparent fiber bundle. The contact portion for contacting the material/tissue includes an exposed, radiation emitting portion of the multicomponent transparent fiber bundle of the fiber optic member. In one form of the invention, the contact portion defines a radiation delivery area with a direction having both radial and axial direction components with respect to a longitudinal axis of the elongated flexible fiber optic member. According to another feature of the invention, the contact portion defines a radiation delivery area wider than a diameter of the distal end of the elongated flexible fiber optic member. In another variation according to the invention, the contact portion defines a radiation delivery area with a direction in only an axial direction with respect to a longitudinal axis of the elongated flexible fiber optic member.
The method and apparatus of the invention allow the transmission and delivery of infrared energy to a highly specific location through a small-diameter flexible component. In the preferred embodiments, the apparatus creates the opportunity for gastroenterologists and physicians and other medical specialists to treat various conditions with infrared energy using a flexible endoscope, which offers direct visualization of the treatment site, pinpoint accuracy of treatment, and immediate visual verification of the status of treatment. The apparatus and method may be used to coagulate human and animal tissue, for treatment of small vascular malformations, removal of tissue, treatment of small tumors or lesions, and hemostasis. The apparatus and method are especially useful for the treatment of hemorrhoids, and possibly other conditions such as angiodysplasia of the colon, gastric antral vascular ectasis (watermelon stomach), esophageal reflux disease, and Barrett's esophagus. The apparatus does not require the passing of electrical current inside the patient's body as in electrocautery and therefore inherently prevents less risk to patients and also has the advantage of being far less expensive than electrocautery devices such as bipolar probes.
These and other features and advantages of the invention will become more apparent when taken in connection with the accompanying drawings and the following detailed description of several embodiments in accordance with the invention.